Medical Coding Manager Overview • The Medical Coding Manager provides expertise in coding adverse events, medications, and data points using MedDRA and WHO Drug dictionaries. • Ensures accuracy and consistency of coded data across studies and projects, adhering to regulatory requirements globally. • Acts as a resource for clinical teams on dictionary and coding-related issues, including Standard MedDRA Queries and Drug Groupings. • Supports study design and database build by reviewing protocols and contributing to coding process documentation. • Participates in the development of adverse events of special interest listings and dictionary term lists under supervision. • Provides training to clinical team members on coding functions, including MedDRA structure and WHO Drug guidelines. • Monitors coding tools and reports technical issues to ensure timelines and quality standards are met. • Collaborates with cross-functional teams to resolve coding queries and ensure successful project outcomes. Medical Coding Manager Key Responsibilities & Duties • Complete medical coding activities for study milestones, ensuring adherence to GCP principles and regulatory requirements. • Maintain synonym lists for accuracy and consistency of coded data across projects and studies. • Participate in data reviews post dictionary migrations to ensure consistency and quality of migrated data. • Consult with medical study directors to resolve coding issues and queries effectively. • Provide training and develop materials relevant to medical coding functions for clinical teams. • Identify gaps in coding dictionaries and propose terms for submission to dictionary vendors. • Monitor coding tools and report technical issues to ensure timelines and quality standards are maintained. • Collaborate with pharmacovigilance and data management teams for SAE coding reconciliation and related activities. Medical Coding Manager Job Requirements • Bachelor's degree in life sciences or equivalent licensure with significant healthcare experience. • Minimum 4 years of coding experience using MedDRA and WHO Drug dictionaries in pharmaceutical or biotechnology settings. • Proficiency in Central Coding, InForm, and dsNavigator or similar coding applications. • In-depth knowledge of MedDRA and WHO Drug dictionaries and their applications. • Strong understanding of GCP principles, regulatory requirements, and industry best practices. • Excellent communication skills and ability to work collaboratively in a team environment. • Experience in data management and pharmacovigilance is a plus. • Commitment to process improvement and streamlining workflows for added value.